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CompletedNCT06836791EpistaxisUpdated Feb 20, 2025

Topical 15% Trichloroacetic Acid Versus Silver Nitrate Cauterization in the Management of Idiopathic Childhood Epistaxis: A Prospective Double-Blinded, Randomized Clinical Trial

An interventional study of chemical cautrizating agents to stop epistaxis and Silver Nitrate in Anterior Epistaxis, sponsored by Youssef Zaki. Completed at 1 site in Egypt. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Youssef Zaki · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
4 Years to 16 Years
Sex
All
01

Study summary

the invistigators aim to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.

Read the detailed description

Epistaxis is a very distressing complaint in otorhinolaryngology that affects nearly 10-12% of the population worldwide . Epistaxis in children is even more common. Approximately half of the children had one or more episodes of epistaxis by the age of 10 .

The source of epistaxis may be anterior or posterior; in children, epistaxis is commonly anterior, originating mainly from the anterior part of the nasal septum called Little's area, in which a confluence of veins named Kiesselbach's plexus is the main area to blame . Anterior epistaxis is commonly related to local trauma, such as nose picking or crust formation, or local inflammation, such as upper airway infection and vestibulitis, due to bacterial inhabitants that lead to crusting and precipitation of epistaxis episodes.

In the literature, there are various modalities for the treatment of anterior epistaxis, such as nose pinching and anterior nasal packing in emergent cases and medical treatment in between attacks, which are considered first aid, and whenever they fail, we shift to alternative methods that are considered invasive but more effective .

One of the currently utilized modalities that has been shown to be effective in the management of epistaxis is chemical cauterization of the prominent vessels in Little's area . In 1932, Little was the first to introduce the idea of using silver nitrate as a chemical cautery agent in the treatment of anterior epistaxis, which results in coagulation of bleeding vessels and tissue destruction .

Another option for chemical cauterization is trichloroacetic acid (TCA), which causes protein denaturation . Trichloroacetic acid is available, inexpensive, and easy to use as a chemical cautery solution. However, there is not yet adequate evidence in the literature for the use of TCA in the treatment of epistaxis.

Therefore, the invistigators aimed to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.

02

Conditions studied

  • Anterior Epistaxis

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03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's enrollment of 170 is above the median of 64 across 81 interventional studies indexed under Epistaxis.

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Lead sponsor

This is the only study on the registry with Youssef Zaki as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients aged between 4 and 16 years at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.

Exclusion criteria

Exclusion Criteria:

  • All patients with documented coagulopathy, those with sinonasal or nasopharyngeal masses, those with active rhinosinusitis or severe allergic rhinitis or severe septal deviation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
170 participants (actual)

Study arms

  • Experimental
    Silver nitrate group

    All procedures were performed as office-based procedures under the influence of local anesthesia. Group (A) Silver nitrate group: Patients were treated with silver nitrate chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in 25% silver nitrate solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of silver nitrate solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks.

    Procedure: chemical cautrizating agents to stop epistaxis · Drug: Silver Nitrate

  • Experimental
    Trichloroacetic acid group

    Group (B) The TCA group: Patients underwent chemical cauterization with 15% TCA solution via the same technique. If there was active nasal bleeding, prior to cauterization, a cotton pack soaked in a nasal decongestant such as oxymetazoline or a 10% lignocaine spray was introduced into the nostril for 5-10 minutes. Patients were offered topical antiseptics for two weeks. Both groups were offered analgesics according to their condition.

    Procedure: chemical cautrizating agents to stop epistaxis · Drug: Trichloroacetic Acid Topical

Interventions

  • Procedurechemical cautrizating agents to stop epistaxis

    All procedures were performed as office-based procedures under the influence of local anesthesia.Patients were treated with chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in chemical cautrizating agents solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of chemical cautrizating agents solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks.

  • silver nitrate is chemical cautrizing agent ,in the study ,the investigators use it in treatment of anterior epistaxis in children by dissolving silver nitrate crystals in normal saline solution before using.

  • trichloroacetic acid is well known peeling agent ,in the study the investigators use it as chemical cautrizing agent to treat anterior epistaxis in children .

    Also known as: TCA

06

What researchers measure

Primary outcomes

  1. rebleeding from the nose

    Patients were followed at regular visits at the 1st, 2nd, 4th, and 12th week intervals. The main outcomes after chemical cauterization were rebleeding from the nose if present during or after the procedure. The success of post chemical cauterization was assessed through the complete cessation of epistaxis. Patients with reported recurrence of bleeding from the nose within 12 weeks of intervention were considered to have failed. rebleeding assessed according to number of bleeds and severity of the attacks.

    Time frame: 12 weeks

Secondary outcomes

  1. pain after procedure

    Pain was assessed via the Wong-Baker FACES® Pain Rating Scale \[9\], which is represented by a series of faces ranging from 0 (smiling face) to 10 (crying face), with 10 referring to the most intense pain. Following a brief explanation, the child can select the face that best represents. We asked the parents to fill out the questionnaire by asking their children to point out the suitable face by the third day postintervention and then reporting it at their 1st-week visit.

    Time frame: 7 days after caurication

07

Study locations

1 site
  • Kafrelsheikh University
    Kafrelsheikh, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Oct 2024, 19 months.

Of 24 interventional studies with no phase under Epistaxis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's 19 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2025
First posted
Feb 20, 2025
StartActual
Mar 1, 2023
Primary completionActual
Oct 1, 2024
CompletionActual
Nov 2, 2024
Last update
Feb 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06836791
Lead sponsor
Youssef Zaki
Collaborators
Faculty of Medicine , Kafrelshiekh University, Egypt.
Responsible party
Youssef Zaki (principal investigator, Kafrelsheikh University) — Sponsor-investigator
First posted
Feb 20, 2025
Start date
Mar 1, 2023
Primary completion
Oct 1, 2024
Completion
Nov 2, 2024
Last update
Feb 20, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Silver Nitrate · Trichloroacetic Acid

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